NCT02646696

Brief Summary

The purpose of this study is tTho establish test-retest reliability of electrodermal markers used to quantify physiologic response to sensation using the Sensory Challenge Protocol in children with and without Autism Spectrum Disorder (ASD).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

January 4, 2016

Last Update Submit

January 4, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Electrodermal Activity in response to sensation

    within six weeks

Study Arms (2)

Children with Autism Spectrum Disorder

Boys between the age of 4 to 11 years old with Autism Spectrum disorder will participate in the Sensory Challenge Protocol which will measure electrodermal activity in response to sensation.

Other: Sensory Challenge Protocol

Typically Developing Children

typically developing boys between the age of 4 to 11 years will participate in the Sensory Challenge Protocol which will measure electrodermal activity in response to sensation.

Other: Sensory Challenge Protocol

Interventions

Measurement of electrodermal activity in response to sensation

Children with Autism Spectrum DisorderTypically Developing Children

Eligibility Criteria

Age4 Years - 11 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of boys between the ages of 4 - 11 years with and without a diagnosis of Autism Spectrum Disorder were recruited from private and public New Jersey Schools, Barpak Occupational Therapy clinic, Bergenfield, New Jersey and Seton Hall University campus.

You may qualify if:

  • Able to sit for 30 minutes and follow simple directions.
  • Children with confirmed Autism Spectrum Disorder via school records or parent report.
  • Typically developing children free of medical or neurological conditions

You may not qualify if:

  • Medical or neurological conditions other than Autism.
  • Hearing loss or visual impairments.
  • Children taking medications known to affect arousal.
  • Children who are not able to follow simple commands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • McIntosh DN, Miller LJ, Shyu V, Hagerman RJ. Sensory-modulation disruption, electrodermal responses, and functional behaviors. Dev Med Child Neurol. 1999 Sep;41(9):608-15. doi: 10.1017/s0012162299001267.

    PMID: 10503919BACKGROUND
  • Miller LJ, Coll JR, Schoen SA. A randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder. Am J Occup Ther. 2007 Mar-Apr;61(2):228-38. doi: 10.5014/ajot.61.2.228.

    PMID: 17436845BACKGROUND
  • Miller LJ, McIntosh DN, McGrath J, Shyu V, Lampe M, Taylor AK, Tassone F, Neitzel K, Stackhouse T, Hagerman RJ. Electrodermal responses to sensory stimuli in individuals with fragile X syndrome: a preliminary report. Am J Med Genet. 1999 Apr 2;83(4):268-79.

    PMID: 10208160BACKGROUND
  • Schoen S, Miller LJ, Brett-Green B, Hepburn S. Psychophysiology of children with ASD. Research in Autism Spectrum Disorders 2: 417-429, 2008

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Barbara M Schupak, PhD

    Barpak GHS, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 6, 2016

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

January 6, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share